fluorouracil, gemcitabine, and radiation therapy in treating patients with cancer of the pancreas

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining radiation therapy with chemotherapy may kill more tumor cells. it is not yet known which treatment regimen is most effective for pancreatic cancer. purpose: randomized phase iii trial to compare the effectiveness of fluorouracil and gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have undergone surgery.

objectives: * compare the overall and disease-free survival of patients with resected adenocarcinoma of the pancreas treated with adjuvant fluorouracil-based chemoradiotherapy preceded and followed by fluorouracil vs gemcitabine. * compare the local-regional and distant disease control in patients treated with these regimens. * compare the acute and late toxic effects of these regimens in these patients. outline: this is a randomized, multicenter study. patients are stratified according to nodal involvement (yes vs no), tumor diameter (less than 3 cm vs 3 cm or greater), and surgical margins (negative vs positive vs unknown). patients are randomized to one of two treatment arms. * arm i: beginning 3-8 weeks after definitive surgical resection, patients receive fluorouracil iv continuously for 3 weeks. beginning 1-2 weeks later, patients receive fluorouracil iv continuously concurrently with radiotherapy 5 days a week for 5.5 weeks. beginning 3-5 weeks after completion of chemoradiotherapy, patients receive fluorouracil iv continuously for 4 weeks every 6 weeks for 2 courses. * arm ii: beginning 3-8 weeks after definitive surgical resection, patients receive gemcitabine iv once weekly for 3 weeks. beginning 1-2 weeks later, patients receive chemoradiotherapy as in arm i. beginning 3-5 weeks after completion of chemoradiotherapy, patients receive gemcitabine iv once weekly for 3 weeks every 4 weeks for 3 courses. patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. projected accrual: a total of 518 patients will be accrued for this study within 8.6 years.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the pancreas * stage t1-4, n0-1 (stage i-iva) * no m1 or nx staging * primary tumor of the pancreas (pancreatic head, neck, uncinate process, or body/tail) and maximum diameter/dimension and tumor status at surgical margin known * prior potentially curative gross resection within 3-8 weeks before study * no non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct carcinoma, or ampullary carcinoma * no recurrent disease * post-resection ca-19-9 level required patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * not specified hematopoietic: * wbc at least 3,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot no greater than 5 times uln renal: * creatinine no greater than 1.5 times uln other: * no significant nausea or vomiting * no prior malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix * able to maintain adequate nutrition (at least 1,500 calories/day) * feeding tube allowed * not pregnant * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * not specified radiotherapy: * no prior radiotherapy surgery: * see disease characteristics

Keywords: stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer adenocarcinoma of the pancreas stage iv pancreatic cancer